MULTITRACE-5

MULTITRACE ® - 5 (TRACE ELEMENTS INJECTION 5, USP) is a sterile nonpyrogenic solution containing five Trace Elements for use as an additive for Total Parenteral Nutrition (TPN). Each mL provides: Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg and Selenium 20 mcg. Each mL Contains: Zinc Sulfate Heptahydrate 4.39 mg (equivalent to 1 mg Zinc); Cupric Sulfate Pentahydrate 1.57 mg (equivalent to 0.4 mg Copper); Manganese Sulfate Monohydrate 0.308 mg (equivalent to 0.1 mg Manganese); Chromic Chloride Hexahydrate 20.5 mcg (equivalent to 4 mcg Chromium); Selenious Acid 32.7 mcg (equivalent to 20 mcg Selenium); and Water for Injection q.s. pH may be adjusted with Sulfuric Acid and/or Sodium Hydroxide. 0.9% Benzyl Alcohol added as an antimicrobial preservative.

This formulation is indicated for use as a supplement to intravenous solutions given for TPN. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese, selenium and chromium and to prevent depletion of endogenous stores of these trace elements and subsequent deficiency symptoms.

Each mL of the solution provides Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg, and Selenium 20 mcg. The suggested dosage ranges for the five trace elements are: ZINC : For the metabolically stable adult receiving TPN, the suggested intravenous dosage level is 2.5 to 4 mg zinc/day. An additional 2 mg zinc/day is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost, or an additional 17.1 mg zinc/kg of stool or ileostomy output is recommended. Frequent monitoring of zinc blood levels is suggested for patients receiving more than the usual maintenance dosage level of zinc. Normal plasma levels for zinc vary from approximately 88 to 112 mcg/100 mL. For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day is suggested. COPPER : For the metabolically stable adult receiving TPN, the suggested additive dosage level is 0.5 to 1.5 mg copper/day. For pediatric patients, the suggested additive dosage level is 20 mcg copper/kg/day. The normal plasma range for copper is approximately 80 to 160 mcg/100 mL. MANGANESE : For the metabolically stable adult receiving TPN, the suggested additive dosage level for manganese is 0.15 mg to 0.8 mg/day. For pediatric patients, a dosage level of 2 to 10 mcg manganese/kg/day is recommended. CHROMIUM : For the metabolically stable adult receiving TPN, the suggested additive dosage level is 10 to 15 mcg chromium/day. The metabolically stable adult with intestinal fluid loss may require 20 mcg chromium/day, with frequent monitoring of blood levels as a guideline for subsequent administration. For pediatric patients, the suggested additive dosage level is 0.14 to 0.20 mcg/kg/day. SELENIUM : For metabolically stable adults receiving TPN, the suggested additive dosage level is 20 to 40 mcg selenium/day. For pediatric patients, the suggested additive dosage level is 3 mcg/kg/day. In adults, selenium deficiency states resulting from long term TPN support, selenium as selenomethionine or selenious acid, administered intravenously at 100 mcg/day for a period of 24 and 31 days, respectively, has been reported to reverse deficiency symptoms without toxicity. The normal whole blood range for selenium is approximately 10 to 37 mcg/100 mL. Periodic monitoring of plasma levels of Zinc, Copper, Manganese, Chromium and Selenium is suggested as a guideline for administration. Aseptic addition of MULTITRACE ® - 5 to parenteral nutrition solutions under laminar flow hood is recommended. The trace elements present in MULTITRACE ® - 5 are physically compatible with the electrolytes and vitamins usually present in parenteral nutrition formulations. Do not directly mix ascorbic acid injection with copper or selenium containing parenteral products in the same syringe or vial, as this admixture may cause the formation of an insoluble precipitate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

MULTITRACE ® - 5 should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.

The amounts of ZINC, COPPER, MANGANESE, CHROMIUM and SELENIUM in the solution are very small and toxicity symptoms due to these trace elements at suggested dosage levels are considered unlikely to occur.